Update on Drugs and Drug News - Number 13 2000

The US FDA gave marketing approval for this receptor-selective retinoid in October 2001, for the treatment of acne vulgaris.

Neurotoxin

Botulinum Toxin
BOTOX®
Allergan

The European Commission of the European Union passed a positive opinion on this neurotoxin in October 2001, for treating focal spasticity of the wrists and hands of adult post-stroke patients after reviewing data from a 126 patient phase III trial. In November 2001, TPP – Canada approved this product for managing post-stroke focal spasticity in adults.

Atopic Dermatitis Agent

Tacrolimus Ointment
Protopic®
Fujisawa

The European Union’s Committee for Prietary Medicinal Products recommended approval of this ointment in October 2001, for the treatment of patients with moderate to severe atopic dermatitis who do not respond to or cannot tolerate conventional treatment.

Mouth and Throat Product

Amlexanox 5% paste
Aptheal®
Strakan Ltd.

The UK Medicines Control Agency (UK MCA) gave marketing approval in October 2001, for the treatment of aphthous ulcers.

HIV/AIDS

Tenofovir Disoproxil Fumarate
Viread™
Gilead Sciences

The US FDA approved this antiretroviral agent in October 2001, for the treatment of HIV infection when taken in combination with other antiretroviral agents.

The US FDA approved this HIV drug resistance test in October 2001, for HIV and AIDS patients. This test can identify which HIV medications have become ineffective because of the virus’ mutation in individual patients. An estimated 60% of HIV/AIDS patients are resistant to at least one of the 15 anti-AIDS drugs.

Drug News

Dear Health Care Professional

Centocor released a "Dear Healthcare Professional" letter addressing new safety information for Remicare® (infliximab). In a Phase II study of 150 patients with moderate to severe CHF, higher incidences of mortality and hospitalization for worsening CHF were seen in the Remicade® treated patients, especially those treated with the higher 10mg/kg dose. The company recommends that therapy not be initiated in CHF patients and that treatment discontinuation be considered in patients with stable concomitant CHF, Remicade® is an unlabelled drug used for treating psoriasis.

Antibacterial Agent

Cubist Pharmaceuticals announced in October 2001, that data from Phase III clinical trials showed in all study populations, the clinical success rates ranged from 74-85% for Cidecin (daptomycin for injection) vs. 73 – 84% for the comparator (i.e., vancomycin or semi-synthetic penicillin) in the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. These results form the basis for an NDA they are filing with the US FDA, which Cubist anticipates will be completed by mid-2002.